Puma Biotechnology Inc (NASDAQ: PBYI) announced the FDA granted Orphan Drug Designation to its Nerlynx for the treatment of breast cancer patients with brain metastases
Food and Drug Administration , FDA, has granted Orphan Drug Designation to NERLYNX, neratinib, for the treatment of breast cancer patients with brain metastases
. "Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer," said Alan H.
These conjugates include xB3-001, Bioasis' lead product conjugate with trastuzumab in development for the treatment of HER2+ breast cancer brain metastases
. The allowed claims of this patent application also cover pharmaceutical compositions containing the conjugates.
The trial, which opened for enrollment in the fall of 2018 and whose lead clinical investigator is Jana Portnow, M.D., city of Hope associate clinical professor in the Department of Medical Oncology and Therapeutics Research, is testing the safety and effectiveness of the CAR T cell therapy for breast cancer patients with brain metastases
who are not effectively being controlled with other therapies.
Approximately 25% of patients with EGFRm NSCLC have brain metastases
at diagnosis, increasing to approximately 40% within two years of diagnosis.6 The presence of brain metastases
often reduces median survival to less than eight months.7
The Investigational New Drug (IND) application of Phase II/III clinical trial for breast cancer carcinoma brain metastases
(BCBS) in China has been approved by the National Medical Products Administration (NMPA).
The researchers likewise found that the nano-vaccine can be used to treat melanoma brain metastases
Lapatinib has been shown to prevent the development of brain metastases
in breast cancer when combined or alone.
The researchers linked data on brain metastases
to investigate rates of brain metastasis in elderly patients.
Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases
Following Radiosurgery (METIS).
(BM) from NSCLC are poor prognosis, with a median survival of 6 months following whole-brain radiotherapy.